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Upcoming

ACCESS Study

October 2026 – Ongoing
PI: Dr. Kigozi Godfrey
Masaka Site
Gilead Sciences, Inc
Overview

About This Project

This is an open-label, single-arm study designed to provide continued access to Gilead HIV treatment regimens for children and adolescents who have completed eligible pediatric HIV clinical trials. Participants will either continue receiving their existing study treatment or switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) if they meet the eligibility criteria.

The study will monitor the long-term safety and tolerability of these antiretroviral therapies while ensuring uninterrupted treatment until participants can access appropriate therapy through routine healthcare or another source. It also aims to support the continued clinical management of pediatric and adolescent participants living with HIV-1 infection following completion of their parent studies.

Goals

Research Objectives

1

To provide continued access to the study drug received in the parent protocol or switch to B/F/TAF for participants who completed a Gilead parent study evaluating drugs for HIV treatment

2

2. To contribute to improved continuity of HIV care, sustained viral suppression, better long-term health outcomes, and a smoother transition from clinical trials to routine HIV treatment services for children and adolescents living with HIV.

Study Details

Protocol Title

GS-US-380-6684: An open label single arm study to provide continued access to study drug to participants who have completed pediatric clinical studies involving Gilead HIV treatments

Study Site

Masaka Site

Principal Investigator

Dr. Kigozi Godfrey

Dr. Kigozi Godfrey

Board Member

gkigozi@ambso.org

Co-Investigators

Dr. Getrude Nakigozi

Dr. Nakigozi Getrude

Board Member

Dr. Fred Nalugoda

Dr. Nalugoda Fred

Board Member

Dr. Noah Kiwanuka

Collaborator

Funding

Gilead Sciences, Inc

Interested in Participating?

Contact our research team to learn about eligibility and how to get involved.

Contact Research Team